Study Evaluating and Comparing Single Dose and Multiple Dose Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese and Caucasian Adults.

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00758030
• Date of registration: 19/09/2008
• Primary sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Public title: Study Evaluating and Comparing Single Dose and Multiple Dose Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese and Caucasian Adults.
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Study to Evaluate and Compare the Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese and Caucasian Subjects.
• Date of first enrolment: March 2004
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00758030
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Contacts

• Name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
• Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy Japanese and Caucasian patients. Japanese patients had to be born in Japan of
Japanese parents and not to have lived outside of Japan for more than 5 years

- Normotensive (5 minute lying down systolic blood pressure of 100-139 mmHg and
diastolic blood pressure of 60-89 mmHg)

- Body Mass Index of 18 to 25 kg/m2

- Considered healthy based on medical history, prestudy physical examination findings,
electrocardiogram, and clinical laboratory evaluation of chemistry, hematology, and
urinalysis values.

Exclusion Criteria:

- History of any significant cardiovascular, respiratory, neurologic, renal, hepatic,
endocrine, psychiatric, or immunologic disorders

- Use of concomitant medication, except for paracetamol and hormonal contraceptives

- Has received an experimental drug and/or used an experimental medical device in the
60 days before the first dose.



Age minimum: 20 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Paliperidone ER OROS

Primary Outcome(s)

Safety and tolerability of extended-release (ER) OROS paliperidone in healthy Japanese and Caucasian adults. Paliperidone plasma concentrations, time profiles and PK parameters after single and multiple dosing for Japanese and Caucasian patients.

Secondary Outcome(s)

Pharmacogenomics: Relationships between composite genetic description or predicted observable traits and the pharmacokinetic parameters of paliperidone and its enantiomers were explored graphically.

Secondary ID(s)

CR004933

Source(s) of Monetary Support

Please refer to primary and secondary sponsors